After much anticipation, approval of the first U.S. biosimilar medications may be around the corner. Biosimilars hold the promise of reducing healthcare spending by offering lower-cost alternatives to highpriced biologic drugs. Biosimilars are not generic versions of existing biologics, however. Generic medications contain an active ingredient identical to that in the reference (‘‘brandname’’) ...

When an innovative biological product goes off-patent, biopharmaceutical or biotechnological companies may file an application for regulatory approval of biosimilar products. In practice, however, important information on the innovative (reference) product may not be available for assessment. Thus, it is important to first establish a reference standard while assessing biosimilarity between a b...

The introduction of targeted biological therapies has revolutionised the treatment of patients with inflammatory joint diseases. These medications are highly effective in reducing disease activity, improving physical function, and retarding or arresting the progression of structural damage. Their relative benefits and risks have been ascertained and contraindications to their use are well known...

As patents expire on innovator products, there is increasing interest in developing biosimilar products globally. Biosimilars are not exact copies and are not considered generic versions of the reference product. They may differ in strength, purity and contain different composition of isoforms and/or various glycosylation profiles, with the consequent alterations in clinical efficacy or safety....

Out of all categories, monoclonal antibody (mAb) therapeutics attract the most interest due to their strong therapeutic potency and specificity. Six of the 10 top-selling drugs are antibody-based therapeutics that will lose patent protection soon. The European Medicines Agency has pioneered the regulatory framework for approval of biosimilar products and approved the first biosimilar antibodies...

ASBTRACT The biopharmaceutical industry has become increasingly focused on developing biosimilars as less expensive therapeutic products. As a consequence, the regulatory approval of 2 antibody-drug conjugates (ADCs), Kadcyla® and Adcetris® has led to the development of biosimilar versions by companies located worldwide. Because of the increased complexity of ADC samples that results from the h...

In this study, we demonstrate the utility of ultra-performance liquid chromatography coupled to mass spectrometry (MS) and ion-mobility spectrometry (IMS) to characterize and compare reference and biosimilar monoclonal antibodies (mAbs) at an advanced level. Specifically, we focus on infliximab and compared the glycan profiles, higher order structures, and their host cell proteins (HCPs) of the...

On November 18, 2010, the European Medicine Agency (EMA) released a draft guideline on similar medicinal products containing monoclonal antibodies (mAbs), following a workshop organized by the agency in London on July 2, 2009. The guideline discusses relevant animal model, non-clinical and clinical studies that are recommended to establish the similarity and the safety of a biosimilar compared ...

Biologic drugs are highly complex molecules produced by living cells through a multistep manufacturing process. The key characteristics of these molecules, known as critical quality attributes (CQAs), can vary based on post-translational modifications that occur in the cellular environment or during the manufacturing process. The extent of the variation in each of the CQAs must be characterized...

Access to bevacizumab, an important component of oncology treatment regimens, may be limited. This survey of oncologists in the US (n = 150), Europe (n = 230), and emerging markets (EM: Brazil, Mexico, and Turkey; n = 130) examined use of and barriers to accessing bevacizumab as treatment of advanced solid tumors. We also assessed the likelihood that physicians would prescribe a bevacizumab bio...